NarcolepsyNCT00174174
Provigil (Modafinil) Study by Taiwan Biotech Co.
A study testing Modafinil in people with Narcolepsy and Cataplexy, run by National Taiwan University Hospital.
Trial summary
The primary objective is to evaluate the therapeutic effect of excessive daytime sleepiness associated with narcolepsy. Both of the subjective and objective sleepiness of the patients were assessed in the experiment by repeat measures. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Narcolepsy, Cataplexy, Sleep Disorders
- What is being tested?
- Modafinil
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2003to not given
- Phase
- Interventional
- 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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Polysomnographic findings of shortened sleep latency less than 5 minutes average of Multiple Sleep Latency Test, and two or more SOREM should be fulfilled.
- Age of 12 y/o to 55 y/o.
- The liver and kidney functions are within normal limits.
- Meeting the strict criteria of narcolepsy described above.
- Wash out any medications which might enhance wakefulness or affect nocturnal sleep two weeks prior to the experiments.
- Willingness to comply with the protocol and signed the written Informed Consent.
Who cannot join
- Patients whose hypersomnia was caused by severely sleep deprived, phase delayed, or suspected long sleeper.
- Patients with concomitant neurological disorder and psychiatric disorders.
- Patients with sleep-related breathing disorders whose apnea/hypopnea index (AHI) was 5 pauses per hour above.
- Patients with Restless Leg Syndrome \& Periodic Limbs Movements whose index was more than 5 per hour.
- Patients who are pregnant or breast-feeding.
About this study
Official title: A Placebo Control, Double Blind, Cross Over Study of Modafinil in Patients With Narcolepsy
The primary objective is to evaluate the therapeutic effect of excessive daytime sleepiness associated with narcolepsy. Both of the subjective and objective sleepiness of the patients were assessed in the experiment by repeat measures.
- Conditions
- Narcolepsy, Cataplexy, Sleep Disorders, Hypersomnolence, Excessive Sleepiness
- Being tested
- Modafinil
- Medical subject headings
- Narcolepsy, Cataplexy, Sleep Wake Disorders, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ModafinilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline in the sleep latency.
Secondary outcomes (4)
Patient's assessment of general level of daytime sleepiness on ESS.
Patient's cognitive function assessed by psychomotor function test (Trail making test, and Digit Symbol Substitution Test).
Patient's sleep quality evaluated by PSQI.
Safety would be evaluated by tabulating and summarizing all adverse events reported.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NarcolepsyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yue-Joe Lee, M.D., Principal investigator, Department of Psychiatry, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00174174
- Sponsor's protocol ID
- 920203l
- Status last verified
- Oct 2004
- First submitted
- 14 Sep 2005
- Last updated
- 15 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo Control, Double Blind, Cross Over Study of Modafinil in Patients With Narcolepsy
- ClinicalTrials.gov ID
- NCT00174174
- Acronym / sponsor ID
- 920203l
- Conditions
- Narcolepsy, Cataplexy, Sleep Disorders, Hypersomnolence, Excessive Sleepiness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2003
- First posted
- 15 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 primary objective is to evaluate the therapeutic effect of excessive daytime sleepiness associated with narcolepsy. Both of the subjective and objective sleepiness of the patients were assessed in the experiment by repeat measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Polysomnographic findings of shortened sleep latency less than 5 minutes average of Multiple Sleep Latency Test, and two or more SOREM should be fulfilled.
- Age of 12 y/o to 55 y/o.
- The liver and kidney functions are within normal limits.
- Meeting the strict criteria of narcolepsy described above.
- Wash out any medications which might enhance wakefulness or affect nocturnal sleep two weeks prior to the experiments.
Key exclusion criteria (5 listed)
- Patients whose hypersomnia was caused by severely sleep deprived, phase delayed, or suspected long sleeper.
- Patients with concomitant neurological disorder and psychiatric disorders.
- Patients with sleep-related breathing disorders whose apnea/hypopnea index (AHI) was 5 pauses per hour above.
- Patients with Restless Leg Syndrome \& Periodic Limbs Movements whose index was more than 5 per hour.
- Patients who are pregnant or breast-feeding.
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 |
|---|---|---|
| Modafinil | Drug | – |
Primary outcome
The change from baseline in the sleep latency.
4 secondary outcomes
Patient's assessment of general level of daytime sleepiness on ESS.
Patient's cognitive function assessed by psychomotor function test (Trail making test, and Digit Symbol Substitution Test).
Patient's sleep quality evaluated by PSQI.
Safety would be evaluated by tabulating and summarizing all adverse events reported.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2005.
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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.
Yue-Joe Lee, M.D. principal investigator
Department of Psychiatry, National Taiwan University
Questions about this trial
What is this clinical trial studying?
A study testing Modafinil in people with Narcolepsy and Cataplexy, run by National Taiwan University Hospital.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 15 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The change from baseline in the sleep latency.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2005.