Tourette's SyndromePhase 4NCT00226824
Safety Study of Galantamine in Tic Disorders
A Phase 4 study testing galantamine in people with Tourette's Syndrome and Motor Tic Disorder, run by Parkinson's Disease and Movement Disorders Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety, tolerability and efficacy of galantamine in tic disorders. The impact of galantamine on commonly associated behaviors (i.e. attention, obsessions, etc.) will also be examined. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Tourette's Syndrome, Motor Tic Disorder, Vocal Tic Disorder
- What is being tested?
- galantamine
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to May 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DSM IV criteria for the diagnosis of Tourette's syndrome, chronic motor or chronic vocal tic disorder
- Accepted method of birth control
Who cannot join
- Preganancy or nursing
- Unstable medical illness
- Unstable psychiatric illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Parkinson's Disease and Movement Disorders Center of Albany Medical Center
Albany, New York, 12205
About this study
Official title: Pilot Examination of Galantamine in the Management of Tic Disorders
The purpose of this study is to determine the safety, tolerability and efficacy of galantamine in tic disorders. The impact of galantamine on commonly associated behaviors (i.e. attention, obsessions, etc.) will also be examined.
Read the detailed description
Modulation of cholinergic activity is a growing focus in neurologic therapeutics especially for dementing disorders such as Alzheimer disease. Treatment with the recently developed cholinesterase inhibitor, galantamine, has demonstrated significant improvement with few issues related to tolerability. In addition to inhibiting the activity of acetylcholinesterase, galantamine also modulates the activity of nicotinic cholinergic receptors by an allosteric mechanism. As a result, galantamine therapy may be beneficial when the response to other agents has been limited.
Cholinesterase inhibitor therapy has been reported to improve motor tics in children with TS refractory to more traditional therapies. Symptoms of co-morbid behavioral disorders, primarily inattention, were also improved. Cholinergic modulation appears a promising avenue for managing tic disorders.
Men and women (18 - 50 years of age) fulfilling DSM IV criteria for the diagnosis of chronic motor tic disorder, chronic vocal tic disorder or Tourette Syndrome and experiencing suboptimal control of tics on current therapy will be enrolled into this open label evaluation of galantamine. A total of 6 visits will be required over 22 weeks. Participants will follow a standard 4 week titration schedule achieving 12 mg bid after 8 weeks. They will maintain at 12 mg bid, or the maximum tolerated dose, for a further 8 weeks and then be withdrawn from therapy. The difference in tic severity prior to and upon completion of therapy will be examined. The impact of treatment upon obsessions/compulsions, attention/concentration, depression, anxiety and quality of life will also be determined.
- Conditions
- Tourette's Syndrome, Motor Tic Disorder, Vocal Tic Disorder
- Being tested
- galantamine
- Keywords
- Tourette's disorder, tic
- Medical subject headings
- Tourette Syndrome, Tic Disorders, Tics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
galantamineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment related adverse experience
Severity Score of the Yale Global Tic Severity Scale
Secondary outcomes (5)
Yale-Brown Obsessive-Compulsive Survey
Connors Adult Attention Deficit Hyperactivity Rating Scale
Hamilton Rating Scale for Depression
Hamilton Rating Scale for Anxiety
Short Form 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2005 (estimated)
- Study startSep 2005
- Study completionMay 2007
Why it stopped: Unable to recruit subjects into the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tourette's SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parkinson's Disease and Movement Disorders Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho-McNeil Neurologics, Inc.
- Investigators
- Donald S Higgins, M.D., Principal investigator, Parkinson's Disease and Movement Disorder Center of Albany Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226824
- Sponsor's protocol ID
- GAL-EMR-4017
- Status last verified
- Aug 2009
- First submitted
- 23 Sep 2005
- Last updated
- 25 Aug 2009
- Results posted
- No
Publications
Hoopes SP. Donepezil for Tourette's disorder and ADHD. J Clin Psychopharmacol. 1999 Aug;19(4):381-2. doi: 10.1097/00004714-199908000-00019. No abstract available.
PubMed 10440471Wilens TE, Biederman J, Wong J, Spencer TJ, Prince JB. Adjunctive donepezil in attention deficit hyperactivity disorder youth: case series. J Child Adolesc Psychopharmacol. 2000 Fall;10(3):217-22. doi: 10.1089/10445460050167322.
PubMed 11052411Hayslett RL, Tizabi Y. Effects of donepezil on DOI-induced head twitch response in mice: implications for Tourette syndrome. Pharmacol Biochem Behav. 2003 Dec;76(3-4):409-15. doi: 10.1016/j.pbb.2003.08.015.
PubMed 14643839Burt T. Donepezil and related cholinesterase inhibitors as mood and behavioral controlling agents. Curr Psychiatry Rep. 2000 Dec;2(6):473-8. doi: 10.1007/s11920-000-0005-7.
PubMed 11122998
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Examination of Galantamine in the Management of Tic Disorders
- ClinicalTrials.gov ID
- NCT00226824
- Acronym / sponsor ID
- GAL-EMR-4017
- Conditions
- Tourette's Syndrome, Motor Tic Disorder, Vocal Tic Disorder
- Keywords
- Tourette's disorder, tic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit subjects into the trial.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Parkinson's Disease and Movement Disorders CenterUniversity, hospital or other
- Collaborators
- Ortho-McNeil Neurologics, Inc.
- Study start
- Sep 2005
- Study completion
- May 2007 (actual)
- First posted
- 27 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety, tolerability and efficacy of galantamine in tic disorders. The impact of galantamine on commonly associated behaviors (i.e. attention, obsessions, etc.) will also be examined.
Detailed description
Modulation of cholinergic activity is a growing focus in neurologic therapeutics especially for dementing disorders such as Alzheimer disease. Treatment with the recently developed cholinesterase inhibitor, galantamine, has demonstrated significant improvement with few issues related to tolerability. In addition to inhibiting the activity of acetylcholinesterase, galantamine also modulates the activity of nicotinic cholinergic receptors by an allosteric mechanism. As a result, galantamine therapy may be beneficial when the response to other agents has been limited.
Cholinesterase inhibitor therapy has been reported to improve motor tics in children with TS refractory to more traditional therapies. Symptoms of co-morbid behavioral disorders, primarily inattention, were also improved. Cholinergic modulation appears a promising avenue for managing tic disorders.
Men and women (18 - 50 years of age) fulfilling DSM IV criteria for the diagnosis of chronic motor tic disorder, chronic vocal tic disorder or Tourette Syndrome and experiencing suboptimal control of tics on current therapy will be enrolled into this open label evaluation of galantamine. A total of 6 visits will be required over 22 weeks. Participants will follow a standard 4 week titration schedule achieving 12 mg bid after 8 weeks. They will maintain at 12 mg bid, or the maximum tolerated dose, for a further 8 weeks and then be withdrawn from therapy. The difference in tic severity prior to and upon completion of therapy will be examined. The impact of treatment upon obsessions/compulsions, attention/concentration, depression, anxiety and quality of life will also be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- DSM IV criteria for the diagnosis of Tourette's syndrome, chronic motor or chronic vocal tic disorder
- Accepted method of birth control
Key exclusion criteria (3 listed)
- Preganancy or nursing
- Unstable medical illness
- Unstable psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| galantamine | Drug | – |
Primary outcome
Treatment related adverse experience
Severity Score of the Yale Global Tic Severity Scale
5 secondary outcomes
Yale-Brown Obsessive-Compulsive Survey
Connors Adult Attention Deficit Hyperactivity Rating Scale
Hamilton Rating Scale for Depression
Hamilton Rating Scale for Anxiety
Short Form 36
Results and safety
The study was stopped early (reason given: Unable to recruit subjects into the trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2009.
- Background: PubMed 10440471Hoopes SP. Donepezil for Tourette's disorder and ADHD. J Clin Psychopharmacol. 1999 Aug;19(4):381-2. doi: 10.1097/00004714-199908000-00019. No abstract available.
- Background: PubMed 11052411Wilens TE, Biederman J, Wong J, Spencer TJ, Prince JB. Adjunctive donepezil in attention deficit hyperactivity disorder youth: case series. J Child Adolesc Psychopharmacol. 2000 Fall;10(3):217-22. doi: 10.1089/10445460050167322.
- Background: PubMed 14643839Hayslett RL, Tizabi Y. Effects of donepezil on DOI-induced head twitch response in mice: implications for Tourette syndrome. Pharmacol Biochem Behav. 2003 Dec;76(3-4):409-15. doi: 10.1016/j.pbb.2003.08.015.
- Background: PubMed 11122998Burt T. Donepezil and related cholinesterase inhibitors as mood and behavioral controlling agents. Curr Psychiatry Rep. 2000 Dec;2(6):473-8. doi: 10.1007/s11920-000-0005-7.
- Parkinson's Disease and Movement Disorders Center of Albany Medical CenterLink provided by the sponsor.
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Exploring the Role of Neuroactive Steroids in Tourette Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald S Higgins, M.D. principal investigator
Parkinson's Disease and Movement Disorder Center of Albany Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing galantamine in people with Tourette's Syndrome and Motor Tic Disorder, run by Parkinson's Disease and Movement Disorders Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit subjects into the trial.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment related adverse experience. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00226824, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2009.