Research & Clinical Trials

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Clinical Trial Readiness for SCA1 and SCA3 (READISCA)

The purpose of this study is to establish the world’s largest cohort of subjects who carry the genetic mutation but have no ataxia symptoms or who have early stage SCA1 or SCA3 and to obtain clinical, imaging and biochemical data, which are necessary for planning future clinical trials and for determining whether a therapy is effective.

  • Study director (local PI): Tetsuo Ashizawa, MD
  • Sponsor: National Institutes of Health (NIH), National Institute of Neurological Disorders & Stroke (NINDS)
  • Recruiting?: Yes
  • Official study title: Clinical Trial Readiness for SCA1 and SCA3
  • ClinicalTrials.gov identifier: NCT03487367
  • Conditions studied: SCA1 and SCA3
  • Intervention Drugs: This is a non-treatment observational study. No interventional drugs will be given.
  • Duration of participation: 5 years (60 months)
  • Participating sites: Columbia University, Emory University, Houston Methodist Research Institute, Johns Hopkins University, Harvard University/Massachusetts General Hospital, Northwestern University, Stanford University, University of Alabama Birmingham,  University of California Los Angeles, University of California San Francisco, University of Colorado, University of Chicago, University of Florida, University of Michigan, University of Minnesota, University of Rochester Medical Center, University of South Florida, University of Utah, German Center for Neurodegenerative Diseases (DZNE)/ University Hospital of Bonn, Bonn, Germany and ICM (Brain and Spine Institute)/Hôpital Pitié Salpêtrière, Paris, France
  • IRB #: Pro00017836
  • IRB approval date: 9/20/2017

Eligibility
Inclusion criteria: Subjects who are between 18-65 years of age who have tested positive for the SCA1 or SCA3 gene mutation, who may or may not currently show signs of ataxia. Or subjects who are at risk for developing SCA1 or SCA3 because they have an affected family member tested positive for the SCA1 or SCA3 mutation. Or healthy volunteers. Subjects who previously participated between 2009-2012 in the CRC-SCA or ESMI may be of any age.
Exclusion criteria: Subjects must not have a known recessive, X-linked and mitochondrial ataxias.

What is involved?

  • Testing: Neurological and physical exams, neuropsychiatric assessments, Imaging (MRI/MRS), blood and CSF (optional) specimen collection.
  • Frequency of visits:
  • Once a year
  • Costs: No costs will be charged for any of the study procedures. The study will cover the cost of all assessments, and tests related to the study. You will receive $100 at time of visit after CSF is collected. You will also receive an additional $50 for completed MR scan visits. You may receive travel reimbursement for taking part in this study.

 For more information, please contact READISCA coordinating center at 713.363.7394 or email U01SCA1&3@houstonmethodist.org

 

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Spinocerebellar Ataxia Natural History (NAFNHS)

The purpose of this study is to collect natural history data in individuals currently experiencing symptoms of spinocerebellar ataxia.

  • Study director (local PI): Tetsuo Ashizawa, MD
  • Sponsor: National Ataxia Foundation
  • Recruiting?: Yes
  • Official study title: Natural History of and Genetic Modifiers in Spinocerebellar Ataxias.
  • ClinicalTrials.gov identifier: NCT01060371
  • Conditions studied: Spinocerebellar 1, 2, 3,6, 7, 8, and 10
  • Intervention Drugs: This is a non-treatment observational study. No interventional drugs will be given.
  • Duration of participation: 5 years (60 months)
  • IRB #: Pro00015684
  • IRB approval date: 5/25/2017

Eligibility
Inclusion criteria: Subjects must be atleast 6 years of age, with symptoms and signs of ataxia.
Exclusion criteria: Subjects must not have a known recessive, X-linked and mitochondrial ataxias

What is involved?

  • Testing: Neurological and physical exams, neuropsychiatric assessments, and blood specimen collection
  • Frequency of Visits: Once a year
  • Costs: No costs will be charged for any of the study procedures. The study will cover the cost of all assessments, and tests related to the study.

For more information, please contact Clinical Research Coordinator Titilayo Olubajo at 346.238.9068 or email tolubajo@houstonmethodist.org

 

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Natural History and Biorepository for Primary Dystonia

The purpose of this study is to collect natural history data in individuals currently experiencing symptoms of Dystonia. Dystonia is a disorder involving excessive involuntary contraction of muscles with repetitive and patterned movements.

  • Study director (local PI): William G. Ondo, MD
  • Sponsor: National Institute of Neurological Disorders and Stroke (NINDS), Office of Rare Diseases (ORD), Allergan and Dystonia Study Group
  • Recruiting?: Yes
  • Official study title: Natural History and Biorepository for primary dystonia
  • ClinicalTrials.gov identifier: NCT01373424
  • Conditions studied: Focal dystonia including cranial dystonia/Meige Syndrome (Including blepharospasm), Jaw or tongue dystonia, laryngeal dystonia (including spasmodic dysphonia) with diagnosis confirmed by nasolaryngoscopy
  • Intervention Drugs: This is a non-treatment observational study. No interventional drugs will be given.
  • Duration of participation: 5 years
  • IRB #: Pro00015684
  • IRB approval date: 12/27/2016

Eligibility
Inclusion criteria:

  • Subjects must be at least 18 years of age and must be diagnosed with one of the conditions studied highlighted above.
  • Subject’s symptoms must have started in the past 5 years
  • Subjects’ last injection of botulinum toxin should be at least 2 months prior to study visit

Exclusion criteria: Subjects must not have evidence of secondary dystonia
What is involved?

  • Testing: neuropsychiatric assessments, questionnaires about medical/family history and current state of mind and blood specimen collection (4 Tablespoons). Subjects will have a neurological exam that will be videotaped.
  • Frequency of Visits: Once a year for five years
  • Costs: No costs will be charged for any of the study procedures. The study will cover the cost of all assessments, and tests related to the study. There is no compensation for participating in this study
For more information, please contact Clinical Research Coordinator Titilayo Olubajo at 346.238.9068 or email tolubajo@houstonmethodist.org

 

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T-CALM Essential Tremor study

The purpose of this study is to test whether an investigational drug called CX-8998 can improve tremors in people diagnosed with Essential tremors as compared with placebo.

  • Study director (local PI): Olga Waln, MD
  • Sponsor:  Cavion Inc.
  • Recruiting?: Yes
  • Official study title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of CX-8998 for Essential Tremor.
  • ClinicalTrials.gov identifier: NCT03101241
  • Conditions studied: Treatment of Essential Tremor
  • Intervention Drugs: CX-8998 and placebo control. Study drug (CX-8998 or placebo) is administered as a pill taken by mouth, twice a day for 5 weeks.
  • Phase: Phase 2
  • Duration of participation: Up to 6 weeks screening period and 5 week treatment period.
  • IRB#: Pro00017175
  • IRB approval date: 6/23/2017

Eligibility
Inclusion criteria: Subjects must be between 18-75 years of age with an established diagnosis of Essential tremors before the age of 65. Subjects may or may not be currently taking one tremor medication.

Exclusion criteria: Subjects must not be receiving more than one anti-tremor medication. Primidone is not an allowed medication. Subjects must not have had any previous surgeries for tremor or received botulinum toxin (botox) injection in the 6 months prior to screening. Subjects must not have any current serious or unstable illness that could interfere with the study.

What is involved?

  • Testing: Neurological (video) and physical exams, neuropsychiatric assessments, ECGs, blood and urine specimen collection, Vital signs
  • Frequency of Visits:
    • Up to 6 week screening period
    • Visits are once a week from Visit 1 to Visit 3. Visit 4 comes 2 weeks after Visit 3. Visit 4 and Visit 5 are a week apart.
  • Costs: No costs will be charged for any of the study procedures. The study will cover the cost of all assessments, the study drug, and tests related to the study. You will receive $55 per completed study visit to help reimburse you for transportation expenses related to your taking part in this study.

 

For more information, please contact Clinical Research Coordinator Titilayo Olubajo at 346.238.9068 or email tolubajo@houstonmethodist.org

 

 

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Restless Legs Syndrome Study

The purpose of this study is to test whether an investigational drug called Ecopipam can treat augmentation in people diagnosed with Restless Legs Syndrome as compared with placebo. You will continue to take your current dopaminergic RLS medication.

  • Study director (local PI): William G. Ondo, MD
  • Sponsor: Restless Legs Syndrome Foundation and Psyadon Pharmaceuticals
  • Recruiting?: Yes
  • Official study title: Treatment of RLS augmentation with Ecopipam, A D1 Specific Antagonist.
  • ClinicalTrials.gov identifier: NCT03218969
  • Conditions studied: Treatment of augmentation in patients with Restless legs syndrome.
  • Intervention Drugs: Ecopipam and placebo control. Study drug (Ecopipam or placebo) is administered as a pill taken by mouth, once a day for 10 weeks. The study is divided into two 5 week phases. During either the first or second phase, you will receive the Ecopipam drug and in the other 5-week phase you will receive look alike placebo pills.
  • Phase: Phase 2a
  • Duration of participation: Up to 4 week screening period and 10 week treatment period
  • IRB#: Pro00016705
  • IRB approval date: 7/12/2017

Eligibility
Inclusion criteria: Subjects must be between 21-80 years of age with an established diagnosis of Restless Legs Syndrome with problematic augmentation, currently on dopaminergic treatment.
Exclusion criteria: Subjects must not be receiving opioid or stimulant medications. Subjects must not have any current serious or unstable illness that could interfere with the study.

What is involved?

  • Testing: Neurological and physical exams, neuropsychiatric assessments, ECGs, blood specimen collection, Vital signs
  • Frequency of Visits:
    • Up to 4 week screening period
    • Visits are bi-weekly (every two weeks) for treatment period
  • Costs: No costs will be charged for any of the study procedures. The study will cover the cost of all assessments, the study drug, and tests related to the study.

For more information, please contact Clinical Research Coordinator Titilayo Olubajo at 346.238.9068 or email tolubajo@houstonmethodist.org

 

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Orthostatic Hypotension in Parkinson’s disease Study (Droxidopa)

The purpose of this study is to test whether Droxidopa (Northera) which received FDA approval for the treatment of episodes of low blood pressure in patients with Parkinson’s disease, improves brain oxygenation and blood flow.
  • Study director (local PI): William G. Ondo, MD
  • Sponsor: Lundbeck LLC
  • Recruiting?: Yes
  • Official study title: Evaluation of Brain Perfusion and Oxygenation in Parkinson’s disease patients with episodes of low Blood Pressure: 4 Weeks comparison of Droxidopa Versus Placebo.
  • ClinicalTrials.gov identifier: NCT03229174    
  • Conditions studied: Treatment of orthostatic hypotension in patients with Parkinson’s disease.
  • Intervention Drugs: Droxidopa and placebo control. Study drug (Droxidopa or placebo) is administered as a pill taken by mouth, three times a day for 4 weeks. The study is divided into two 4 week phases. During the first phase, you will receive either the Droxidopa drug or look alike placebo and in the other 4-week phase you will receive the Droxidopa drug.
  • Phase: Phase 4
  • Duration of participation: 8 week treatment period
  • IRB#: Pro00013931
  • IRB approval date: 7/14/2016

Eligibility
Inclusion criteria: Subjects must be between 18-85 years of age with an established diagnosis of Idiopathic Parkinson’s disease with documented drop in blood pressure while standing within a month of inclusion.
Exclusion criteria: Subjects must not be receiving Midodrine or already be taking Droxidopa (Northera). Subjects must not have any current serious or unstable illness including cardiovascular, hepatic, renal, respiratory, neurologic, psychiatric, or other conditions that could interfere with the study.

What is involved?

  • Testing: Neurological (video) and physical exams, neuropsychiatric assessments, gait assessment, Transcranial Doppler and Tilt table assessments, Vital signs
  • Frequency of Visits:
    • Total of 3 visits; Baseline Visit, Week 4 Visits and Week 8 Visits.
    • Visits are 4 weeks apart.
  • Costs: No costs will be charged for any of the study procedures. The study will cover the cost of all assessments, the study drug, and tests related to the study. You will receive $30 per completed study visit to help reimburse you for transportation expenses related to your taking part in this study.

For more information, please contact Clinical Research Coordinator Chia Arif at 713.363.8390 or email carif@houstonmethodist.org

 

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