Restless Leg Syndrome (RLS)Phase 1NCT07453862
Novel Calcium Channel Modulators in RLS and Variants: Efficacy & Safety
A Phase 1 study testing Crisugabalin in people with Restless Leg Syndrome (RLS) and Variant Restless Legs Syndrome, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
The goal of this [study type: clinical trial] is to [primary purpose: evaluate the efficacy and safety of a novel calcium channel modulator in treating Restless Legs Syndrome (RLS) and its variant subtypes] in [describe participant population/primary condition: adult patients aged 18-75 years with confirmed RLS or its… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Restless Leg Syndrome (RLS), Variant Restless Legs Syndrome
- What is being tested?
- Crisugabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2026to 31 Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Aged 18-75 years, regardless of gender.
- 2. Meets the diagnostic criteria for typical Restless Legs Syndrome (RLS) (IRLSSG criteria) or variant RLS confirmed by a neurologist.
- 3. Moderate to severe RLS (IRLS score ≥11).
- 4. Able to understand and comply with the study protocol, and provides written informed consent.
Who cannot join
- 1. Secondary RLS (e.g., iron deficiency anemia with serum ferritin <30μg/L, renal dysfunction with eGFR <30ml/min, pregnancy/lactation, drug-induced RLS with unadjustable medications).
- 2. Severe central nervous system diseases (e.g., status epilepticus, severe dementia, stroke within 3 months).
- 3. Severe cardiovascular diseases (e.g., congestive heart failure, uncontrolled hypertension with SBP≥180mmHg or DBP≥110mmHg).
- 4. Severe liver or kidney dysfunction (ALT/AST >3×ULN, eGFR <30mL/min/1.73m²).
- 5. Active mental illnesses (e.g., schizophrenia, acute bipolar disorder).
- 6. Hypersensitivity to Keligabalin Benzenesulfonic Acid or its excipients.
- 7. Participation in other clinical trials within 1 month, inability to cooperate with follow-up, or history of substance abuse.
- 8. Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Capital Medical University Affiliated Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050
Houzhen Tuo, 13683628005, tuohouzhen@ccmu.edu.cn
Wenlu Zhao, 13017688128, 912977992@qq.com
About this study
Official title: Observation of Efficacy and Safety of Novel Calcium Channel Modulators in the Treatment of Restless Legs Syndrome and Its Variant Subtypes
The goal of this [study type: clinical trial] is to [primary purpose: evaluate the efficacy and safety of a novel calcium channel modulator in treating Restless Legs Syndrome (RLS) and its variant subtypes] in [describe participant population/primary condition: adult patients aged 18-75 years with confirmed RLS or its variant subtypes, who meet the study's eligibility criteria]. The main question[s] it aims to answer [is/are]:
- Does the novel calcium channel modulator improve RLS-related symptoms (assessed by the International Restless Legs Syndrome Study Group Rating Scale, IRLS) after the treatment period?
- What is the safety profile (incidence of adverse events) of this calcium channel modulator in RLS patients?
Read more
Participants will [describe the main tasks participants will be asked to do, interventions they'll be given]:
- Receive oral administration of the novel calcium channel modulator (40mg twice daily) for 12 consecutive weeks
- Complete scheduled follow-up visits for symptom assessments, safety monitoring, and questionnaire completion
- Being tested
- Crisugabalin
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrisugabalinDrug
Participants will receive oral administration of Crisugabalin for 12 consecutive weeks. No other drugs affecting RLS symptoms will be allowed during the study. Clinical assessments and safety monitoring will be conducted at scheduled follow-up visits.
| Study group | Role | What they receive |
|---|---|---|
| Crisugabalin Treatment Arm | Experimental | Not described Receives: Drug: Crisugabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in International Restless Legs Syndrome Scale (IRLS) Score from Baseline to Week 12
The International Restless Legs Syndrome Scale (IRLS) is a 10-item scale used to assess the severity of restless legs syndrome symptoms, including urge to move, sleep disturbance, and daytime impairment. The scale ranges from 0 to 40 points, with lower scores indicating less severe symptoms and a score of 0 indicating no symptoms. This outcome measure assesses the absolute change in IRLS total score from baseline (pre-treatment) to Week 12 (end of treatment).
Measured: Baseline (pre-treatment) and Week 12 (end of treatment)
Change in International Restless Legs Syndrome Scale (IRLS) Score from Baseline to Week 12
The International Restless Legs Syndrome Scale (IRLS) is a 10-item scale used to assess the severity of restless legs syndrome symptoms, including urge to move, sleep disturbance, and daytime impairment. The scale ranges from 0 to 40 points, with lower scores indicating less severe symptoms. This primary efficacy endpoint is defined as the percentage of participants achieving a ≥50% reduction in IRLS total score from baseline to Week 12, which is considered a clinically meaningful treatment response.
Measured: Baseline (pre-treatment) and Week 12 (end of treatment)
Secondary outcomes (1)
Change in Restless Legs Syndrome Quality of Life (QoL-RLS) Score from Baseline to Week 12
This outcome evaluates the effect of treatment on participants' quality of life, focusing on physical, emotional, and social functioning related to RLS symptoms. The Restless Legs Syndrome Quality of Life (QoL-RLS) scale is a disease-specific instrument designed to measure the impact of RLS on daily life. The scale ranges from 0 to 100 points, with higher scores indicating better quality of life related to RLS symptoms. This outcome measure assesses the change in QoL-RLS total score from baseline (pre-treatment) to Week 12 (end of treatment).
Measured: Baseline (pre-treatment) and Week 12 (end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start10 Mar 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Restless Leg Syndrome (RLS)Studies of the same condition, open and under way.
- More trials run by Beijing Friendship 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453862
- Sponsor's protocol ID
- BFH20251127008
- Status last verified
- Mar 2026
- First submitted
- 2 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This study is in the exploratory stage, and the plan for sharing individual participant data (IPD) has not yet been finalized. The decision will be made based on the study results, publication requirements, and ethical considerations at the completion of the study.
Publications
Trenkwalder C, Allen R, Hogl B, Clemens S, Patton S, Schormair B, Winkelmann J. Comorbidities, treatment, and pathophysiology in restless legs syndrome. Lancet Neurol. 2018 Nov;17(11):994-1005. doi: 10.1016/S1474-4422(18)30311-9. Epub 2018 Sep 21.
PubMed 30244828Suzuki K, Suzuki S, Miyamoto M, Miyamoto T, Matsubara T, Nozawa N, Arikawa T, Nakajima I, Hirata K. Involvement of legs and other body parts in patients with restless legs syndrome and its variants. J Neurol Sci. 2019 Dec 15;407:116519. doi: 10.1016/j.jns.2019.116519. Epub 2019 Oct 20.
PubMed 31669730Ishizuka K, Ohira Y. Restless Chest Syndrome: A Rare Variant of Restless Legs Syndrome. Eur J Case Rep Intern Med. 2022 Jul 6;9(7):003398. doi: 10.12890/2022_003398. eCollection 2022.
PubMed 36051162Jung Y, Hassan A, St Louis EK, Robertson CE. Restless mouth syndrome. Neurol Clin Pract. 2017 Jun;7(3):e29-e30. doi: 10.1212/CPJ.0000000000000280. No abstract available.
PubMed 30107007Allen RP, Picchietti DL, Garcia-Borreguero D, Ondo WG, Walters AS, Winkelman JW, Zucconi M, Ferri R, Trenkwalder C, Lee HB; International Restless Legs Syndrome Study Group. Restless legs syndrome/Willis-Ekbom disease diagnostic criteria: updated International Restless Legs Syndrome Study Group (IRLSSG) consensus criteria--history, rationale, description, and significance. Sleep Med. 2014 Aug;15(8):860-73. doi: 10.1016/j.sleep.2014.03.025. Epub 2014 May 17.
PubMed 25023924
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of Efficacy and Safety of Novel Calcium Channel Modulators in the Treatment of Restless Legs Syndrome and Its Variant Subtypes
- ClinicalTrials.gov ID
- NCT07453862
- Acronym / sponsor ID
- BFH20251127008
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 10 Mar 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 6 Mar 2026 (actual)
- 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 goal of this [study type: clinical trial] is to [primary purpose: evaluate the efficacy and safety of a novel calcium channel modulator in treating Restless Legs Syndrome (RLS) and its variant subtypes] in [describe participant population/primary condition: adult patients aged 18-75 years with confirmed RLS or its variant subtypes, who meet the study's eligibility criteria]. The main question[s] it aims to answer [is/are]:
- Does the novel calcium channel modulator improve RLS-related symptoms (assessed by the International Restless Legs Syndrome Study Group Rating Scale, IRLS) after the treatment period?
- What is the safety profile (incidence of adverse events) of this calcium channel modulator in RLS patients?
Participants will [describe the main tasks participants will be asked to do, interventions they'll be given]:
- Receive oral administration of the novel calcium channel modulator (40mg twice daily) for 12 consecutive weeks
- Complete scheduled follow-up visits for symptom assessments, safety monitoring, and questionnaire completion
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Crisugabalin Treatment Arm | Experimental | Drug: Crisugabalin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Aged 18-75 years, regardless of gender.
- 2. Meets the diagnostic criteria for typical Restless Legs Syndrome (RLS) (IRLSSG criteria) or variant RLS confirmed by a neurologist.
- 3. Moderate to severe RLS (IRLS score ≥11).
- 4. Able to understand and comply with the study protocol, and provides written informed consent.
Key exclusion criteria (8 listed)
- 1. Secondary RLS (e.g., iron deficiency anemia with serum ferritin <30μg/L, renal dysfunction with eGFR <30ml/min, pregnancy/lactation, drug-induced RLS with unadjustable medications).
- 2. Severe central nervous system diseases (e.g., status epilepticus, severe dementia, stroke within 3 months).
- 3. Severe cardiovascular diseases (e.g., congestive heart failure, uncontrolled hypertension with SBP≥180mmHg or DBP≥110mmHg).
- 4. Severe liver or kidney dysfunction (ALT/AST >3×ULN, eGFR <30mL/min/1.73m²).
- 5. Active mental illnesses (e.g., schizophrenia, acute bipolar disorder).
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 |
|---|---|---|
| CrisugabalinParticipants will receive oral administration of Crisugabalin for 12 consecutive weeks. No other drugs affecting RLS symptoms will be allowed during the study. Clinical assessments and safety monitoring will be conducted at scheduled follow-up visits. | Drug | Crisugabalin Treatment Arm |
Primary outcome
Change in International Restless Legs Syndrome Scale (IRLS) Score from Baseline to Week 12
Time frame: Baseline (pre-treatment) and Week 12 (end of treatment)
The International Restless Legs Syndrome Scale (IRLS) is a 10-item scale used to assess the severity of restless legs syndrome symptoms, including urge to move, sleep disturbance, and daytime impairment. The scale ranges from 0 to 40 points, with lower scores indicating less severe symptoms and a score of 0 indicating no symptoms. This outcome measure assesses the absolute change in IRLS total score from baseline (pre-treatment) to Week 12 (end of treatment).
Change in International Restless Legs Syndrome Scale (IRLS) Score from Baseline to Week 12
Time frame: Baseline (pre-treatment) and Week 12 (end of treatment)
The International Restless Legs Syndrome Scale (IRLS) is a 10-item scale used to assess the severity of restless legs syndrome symptoms, including urge to move, sleep disturbance, and daytime impairment. The scale ranges from 0 to 40 points, with lower scores indicating less severe symptoms. This primary efficacy endpoint is defined as the percentage of participants achieving a ≥50% reduction in IRLS total score from baseline to Week 12, which is considered a clinically meaningful treatment response.
1 secondary outcome
Change in Restless Legs Syndrome Quality of Life (QoL-RLS) Score from Baseline to Week 12
Time frame: Baseline (pre-treatment) and Week 12 (end of treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Background: PubMed 30244828Trenkwalder C, Allen R, Hogl B, Clemens S, Patton S, Schormair B, Winkelmann J. Comorbidities, treatment, and pathophysiology in restless legs syndrome. Lancet Neurol. 2018 Nov;17(11):994-1005. doi: 10.1016/S1474-4422(18)30311-9. Epub 2018 Sep 21.
- Background: PubMed 31669730Suzuki K, Suzuki S, Miyamoto M, Miyamoto T, Matsubara T, Nozawa N, Arikawa T, Nakajima I, Hirata K. Involvement of legs and other body parts in patients with restless legs syndrome and its variants. J Neurol Sci. 2019 Dec 15;407:116519. doi: 10.1016/j.jns.2019.116519. Epub 2019 Oct 20.
- Background: PubMed 36051162Ishizuka K, Ohira Y. Restless Chest Syndrome: A Rare Variant of Restless Legs Syndrome. Eur J Case Rep Intern Med. 2022 Jul 6;9(7):003398. doi: 10.12890/2022_003398. eCollection 2022.
- Background: PubMed 30107007Jung Y, Hassan A, St Louis EK, Robertson CE. Restless mouth syndrome. Neurol Clin Pract. 2017 Jun;7(3):e29-e30. doi: 10.1212/CPJ.0000000000000280. No abstract available.
- Background: PubMed 25023924Allen RP, Picchietti DL, Garcia-Borreguero D, Ondo WG, Walters AS, Winkelman JW, Zucconi M, Ferri R, Trenkwalder C, Lee HB; International Restless Legs Syndrome Study Group. Restless legs syndrome/Willis-Ekbom disease diagnostic criteria: updated International Restless Legs Syndrome Study Group (IRLSSG) consensus criteria--history, rationale, description, and significance. Sleep Med. 2014 Aug;15(8):860-73. doi: 10.1016/j.sleep.2014.03.025. Epub 2014 May 17.
- Individual participant dataSharing planned: Undecided. This study is in the exploratory stage, and the plan for sharing individual participant data (IPD) has not yet been finalized. The decision will be made based on the study results, publication requirements, and ethical considerations at the completion of the study.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Crisugabalin in people with Restless Leg Syndrome (RLS) and Variant Restless Legs Syndrome, run by Beijing Friendship Hospital at 1 site in China.
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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 6 Mar 2026. 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 China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenlu Zhao (13017688128, 912977992@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in International Restless Legs Syndrome Scale (IRLS) Score from Baseline to Week 12 (time frame: Baseline (pre-treatment) and Week 12 (end of treatment)). 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 NCT07453862, which also lists 5 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 6 Mar 2026.